Anlotinib for Patients With Platinum Resistant or Refractory Ovarian Cancer

• Status: Recruiting
• Trial end date: 2022-04-25
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to evaluate the efficacy and toxicity of anlotinib in patients with platinum resistant or refractory ovarian cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Criteria

Inclusion Criteria:

1. Female, age ≥18 years and ≤70 years, signed informed consent.

2. Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.

3. Platinum resistant ovarian cancer (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) OR platinum refractory ovarian cancer (defined as progressing while on a platinum-based chemotherapy)

4. At least treated with one line of platinum-based chemotherapy

5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

6. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version or CA125

7. Patients must have a life expectancy of at least 3 months.

8. Patients must have adequate organ function.

Exclusion Criteria:

1. Had prior exposure to anlotinib or has known allegies to any of the excipients, Inadequately controlled hypertension

2. History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.

3. History of abdominal fistula or gastrointestinal perforation within 28 days prior to Day 1

4. Major surgical procedure within 28 days prior to Day 1, Serious, non-healing wound, active ulcer, bowel obstruction within 28 days prior to Day 1

5. Symptomatic central nervous system (CNS) metastasis